Amplatz G03460Recalls & reported problems
Cook Incorporated · Amplatz Extra Stiff Wire Guide · Class 2
Quick summary
This Cook Medical Amplatz Extra Stiff Wire Guide is a stiff support wire used to help guide catheters and devices into place during procedures. The 45 reports mostly describe the wire's material protruding or unraveling, wires snapping or breaking during insertion, and hair-like contamination found inside the packaging before use. Reports also mention one death and one injury, such as a heart puncture and a dissected artery. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00827002034600), received between Feb 21, 2017 and Dec 31, 2025 — classified as 1 death, 1 injury, 43 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (14 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion14
- Unraveled Material8
- Device Contaminated During Manufacture or Shipping7
- Break6
- Contamination /Decontamination Problem6
- Adverse Event Without Identified Device or Use Problem2
- Device Contamination with Chemical or Other Material2
- Flaked2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Patient Involvement14
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
- Insufficient Information2
- Cardiac Perforation1
- Exsanguination1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
DeathDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, DURING A PULSED FIELD ABLATION (PFA) PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND EXPIRED. ANOTHER MANUFACTURER'S CATHETER WAS PLACED IN THE CORONARY SINUS (CS). ANOTHER MANUFACTURER'S 13F INTRODUCER WAS THEN INTRODUCED INTO THE RIGHT ATRIUM AND TRANSSEPTAL PUNCTURE WAS PERFORMED IN ONE ATTEMPT WITH ANOTHER MANUFACTURER'S TRANSSEPTAL NEEDLE. 10,000 INTERNATIONAL UNITS (I.U.) OF HEPARIN WERE ADMINISTERED TO THE PATIENT. AFTER PREPARING THE OTHER MANUFACTURER'S CATHETER, THE CATHETER WAS ADVANCED OVER A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE AND INTO THE LEFT ATRIUM. A SHADOW WAS THEN OBSERVED AROUND THE HEART SILHOUETTE ON X-RAY AND A DECREASE IN SYSTOLIC BLOOD PRESSURE WAS NOTED FROM 100 TO 70 WITHIN 1-2 MINUTES. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED A LARGE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT WAS VERY CHALLENGING DUE TO THE PATIENT'S BODY MASS (125KG), THE POSITION OF THE PATIENT¿S LIVER (IN FRONT OF THE PUNCTURE AREA), AND SIMULTANEOUS RESUSCITATION EFFORTS. SEVERAL ATTEMPTS WERE NEEDED TO ACHIEVE THE PUNCTURE AND INTRODUCE THE DRAIN INTO THE PERICARDIUM. AFTER MORE THAN 60 MINUTES OF RESUSCITATION AND DRAINI
Patient problems: Cardiac Perforation; Exsanguination; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion
MAUDE report 23935218 ↗MalfunctionSep 8, 2025Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICES ON (B)(6) 2025, THE INNER WIRE WAS PROTRUDING NEAR THE DISTAL END OF BOTH DEVICES.
Patient problems: Insufficient Information
MAUDE report 22996024 ↗MalfunctionAug 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A HAIR OR HAIR-LIKE FOREIGN MATTER WAS DISCOVERED INSIDE THE PACKAGING OF THE 'SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE'. THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730916 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, DURING A PROCEDURE INVOLVING ANEURYSM REPAIR AND STENT GRAFT PLACEMENT, DURING WHICH A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE (REPORTED UNDER PATIENT IDENTIFIER (B)(6)) AND A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE (REPORTED UNDER PATIENT IDENTIFIER (B)(6)) WERE USED, THE PATIENT EXPERIENCED A DISSECTION OF THE LEFT SUBCLAVIAN ARTERY. GENERAL ANESTHESIA WAS ADMINISTERED FOR THE PROCEDURE, AND PERCUTANEOUS ACCESS WAS OBTAINED IN THE LEFT AND RIGHT FEMORAL ARTERIES. CUT-DOWN ACCESS WAS OBTAINED IN THE RIGHT AXILLARY ARTERY. A 9X57 PERIPHERAL STENT WAS SUCCESSFULLY PLACED IN THE LEFT SUBCLAVIAN ARTERY, WHICH WAS RE-VASCULARIZED WITH A FENESTRATED BRANCHED DEVICE. STENT PATENCY WAS MAINTAINED, WITH NORMAL END ARTERY PERFUSION. THE WIRES USED DURING THE PROCEDURE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED, WITHOUT ANY NOTED DEVICE DEFICIENCIES. A LEFT SUBCLAVIAN ARTERY INJURY (DISSECTION) WAS REPORTED DURING THE PROCEDURE; HOWEVER, THE INJURY DID NOT REQUIRE TREATMENT. PER THE REPORTER, THE INJURY WAS CAUSALLY RELATED TO A STENT, AS THE DISSECTION OCCURRED AFTER PLACEMENT OF THE BRIDGING STENT, WHILE POSITIONING THE DEVICE. PER THE R
Patient problems: Vascular Dissection
MAUDE report 21753451 ↗MalfunctionMar 27, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT AN EYELASH-LIKE FOREIGN SUBSTANCE WAS FOUND IN THE PACKAGING OF THE 'SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE'. THE ISSUE WAS DISCOVERED PRIOR TO DELIVERY TO THE HOSPITAL BY THE DISTRIBUTOR STAFF, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710393 ↗MalfunctionMar 12, 2025Unraveled Material; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING A PATENT DUCTUS ARTERIOSUS (PDA) VIA FEMORAL ACCESS, A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE ¿FRACTURED¿ WHILE INTRODUCING THE WIRE THROUGH AN UNSPECIFIED LONG SHEATH. THE USER ALTERED THE WIRE FROM ITS ORIGINAL CONDITION PRIOR TO USE, AND RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE WIRE. THE ANATOMY WAS NOT STENOSED, TORTUOUS, CALCIFIED, OR SCARRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON RETURN AND EVALUATION OF THE DEVICE, THE SAFETY WIRE AND MANDRIL PROTRUDED FROM UNRAVELED COILS. THE WIRE WAS NOT SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583135 ↗MalfunctionNov 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678698 ↗MalfunctionJul 26, 2024Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion
ADDITIONAL INFORMATION WAS RECEIVED, NOTING THAT THE MANDRIL PROTRUDED FROM THE WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19840039 ↗MalfunctionJul 26, 2024Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion
AS REPORTED, PRIOR TO USE DURING PREPARATION FOR AN UNKNOWN PROCEDURE, "ROUGHNESS" WAS NOTED NEAR THE TIP OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THIS WAS NOTED WHEN THE USER WAS ATTEMPTING TO SHAPE THE WIRE BY HAND AND WITH THE PURPLE INTRODUCER INCLUDED WITH THE WIRE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839900 ↗MalfunctionJul 26, 2024Break; Break
AS REPORTED, PRIOR TO USE DURING PREPARATION FOR AN UNKNOWN PROCEDURE, "ROUGHNESS" WAS NOTED NEAR THE TIP OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THIS WAS NOTED WHEN THE USER WAS ATTEMPTING TO SHAPE THE WIRE BY HAND AND WITH THE PURPLE INTRODUCER INCLUDED WITH THE WIRE. THE ROUGH FRAGMENT REPORTEDLY FELL OFF THE WIRE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839782 ↗MalfunctionMay 3, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT A COOK WIRE GUIDE BROKE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19239909 ↗MalfunctionApr 22, 2024Unraveled Material; Material Split, Cut or Torn; Unraveled Material; Material Split, Cut or Torn
AS REPORTED, DURING A PROCEDURE INVOLVING IMPLANTATION OF ANOTHER MANUFACTURER'S ASD (ATRIAL SEPTAL DEFECT) DEVICE, A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE "SPLIT/TWISTED". AS THE OTHER MANUFACTURER'S ASD IMPLANT DEVICE WAS ADVANCED OVER THE COMPLAINT DEVICE, THE WIRE SPLIT/TWISTED. THE WIRE WAS REMOVED BY A VASCULAR SURGEON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154933 ↗MalfunctionMar 28, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997426 ↗MalfunctionNov 6, 2023Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18074464 ↗MalfunctionAug 10, 2023Break; Unraveled Material; Material Protrusion/Extrusion; Break; Unraveled Material; Material Protrusion/Extrusion
UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE ON 16AUG2023, THE WIRE WAS UNRAVELED, AND THE MANDRIL AND SAFETY WIRE PROTRUDED FROM THE DEVICE. THE DISTAL WELD BALL WAS INTACT. THE WIRE DID NOT SEPARATE AS ORIGINALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17498686 ↗MalfunctionApr 12, 2023Sharp Edges; Sharp Edges
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. UPON RETURN AND EVALUATION OF THE DEVICE, THE WIRE WAS BENT; HOWEVER, NO SHARP EDGES WERE PRESENT ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16725544 ↗MalfunctionFeb 21, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16409620 ↗MalfunctionSep 1, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, PRIOR TO AN UNSPECIFIED PROCEDURE, A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE "SPLINTERED". THE DEVICE DID NOT MAKE PATIENT CONTACT. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335686 ↗MalfunctionMar 28, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, WHEN PREPARING THE DEVICE FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT, THE INNER CORE OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE PROTRUDED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE FROM THE SAME PRODUCT LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13934367 ↗MalfunctionDec 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13117348 ↗MalfunctionSep 20, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12499435 ↗MalfunctionApr 2, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11607097 ↗MalfunctionDec 8, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10968037 ↗MalfunctionJul 13, 2020Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Patient Involvement
MAUDE report 10263740 ↗MalfunctionApr 8, 2020Material Frayed; Material Frayed
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Patient Involvement
MAUDE report 9937821 ↗
Other WIRE, GUIDE, CATHETER devices
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- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.